drugset / Trial / NCT00312897
Omega-3 Fatty Acids in Adolescent Depression
Phase 2
Completed
57 enrolled
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH) · collabNational Center for Research Resources (NCRR) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment. Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.
Timeline
- Start
- 2005-12
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omega-3 fatty acids | Unknown | — | — |
Indications
No indication recorded.